AirLife Resuscitation Device — Class I medical device recall Z-2553-2018
Terminated recall by Vyaire Medical, reported 2018-08-15, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of t
| Recall number | Z-2553-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vyaire Medical, Mettawa, IL, United States |
| Recall initiated | 2018-05-08 |
| Classified | 2018-08-08 |
| Reported by FDA | 2018-08-15 |
| Terminated | 2020-07-07 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PR, SD, TX, VA, WA |
| Quantity | 15,714 units |
| Lot numbers | 0001209831, 0001209837, 0001209839, 0001210201, 0004002563, 0004003205 |
| Model numbers | 2K8008, 2K8018, 2K8039, RE1DK5445D |
Product
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit with neonatal, infant and pediatric masks, Part Number RE1DK5445D; d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039 Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.
Reason for recall
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2553-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.